Senior Director, Medical Information

1 month ago

US Remote East Coast, UK, United Kingdom myGwork Full time

This job is with Autolus Therapeutics, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.

Role Summary

Autolus Therapeutics is seeking a dynamic and experienced Senior Director of Medical Information to lead the development and execution of the Medical Information function. This individual will be responsible for overseeing the creation, management, and dissemination of scientifically accurate and balanced medical information for Autolus’ portfolio of cellular therapies. The Senior Director will play a critical role in supporting both internal teams and external stakeholders, including healthcare professionals and patients, ensuring the highest standards of medical communication.

Key Responsibilities

• Leadership and Strategy:

• Lead and develop the Medical Information function to support Autolus' mission of advancing innovative cellular therapies.

• Establish strategic goals for the Medical Information function, aligning with broader Medical Affairs and corporate objectives.

• Provide leadership in developing and executing a comprehensive Medical Information strategy

• Medical Content Development and Review:

• Oversee the development, review, and approval of high-quality, accurate, and compliant medical content, including standard response letters, FAQs, and product dossiers.

• Ensure medical information materials comply with regulatory requirements and are aligned with scientific evidence.

• Collaborate with cross-functional teams (Medical Affairs, Regulatory, Clinical Development, Commercial) to ensure consistency and accuracy of information provided to healthcare professionals, patients, and internal teams.

• Stakeholder Engagement and Support:

• Serve as the primary point of contact for medical information requests from healthcare providers, patients, and internal stakeholders.

• Respond to complex medical inquiries related to Autolus’ therapies, ensuring all responses are scientifically sound, balanced, and compliant with industry regulations.

• Develop and maintain relationship with Medical Information Call Center to establish a medical inquiry database to track and analyze trends in medical information requests, utilizing insights to inform strategy and content development.

Team Leadership and Development:

• Foster a culture of collaboration and scientific excellence within Medical Affairs.

• Compliance and Regulatory Oversight:

• Ensure all medical information activities comply with relevant laws, guidelines, and regulations, including FDA, EMA, and local regulatory authorities.

• Collaborate with legal, regulatory, and compliance teams to ensure all materials and activities are in line with corporate standards and healthcare regulations.

Continuous Improvement and Innovation:

• Continuously assess and improve medical information processes, ensuring efficiency, accuracy, and scalability as the portfolio grows.

• Leverage technology and innovation to optimize the delivery of medical information, including digital platforms and AI tools. .

Experience

• Solid business mentality including leadership skills; innovative, solution-oriented, and critical thinking with performance-focused drive to achieve objectives and execute tactics.

• Proven history of process improvement and team building.

• Experienced in attaining customer insights and driving change in day-to-day operations.

• Ability to operate in an environment with little direction and produce exceptional results.

• Excellent communication, interpersonal, and influencing skills, with the ability to communicate effectively across different channels to a variety of audiences.

• Acts with credibility and clarity of purpose to build and maintain effective and collaborative relationships.

• Application of a curious mindset, employing active listening skills and asking open questions to gain medical intelligence and uncover current thinking.

• Capable ofself-directed learning and having a growth mindset.

• Capable to adapt, organize, prioritize, and work effectively and collaboratively in multifunctional teams in a dynamic field-based environment.

• Strong personal integrity reflected in all actions and behaviors.

Skills/Specialist knowledge

• Advanced degree in a relevant scientific or clinical discipline (PharmD, MD, PhD) preferred. • 10+ years of experience in Medical Information within the pharmaceutical or biotech industry,

• In-depth knowledge of regulatory and compliance requirements related to medical communications and the dissemination of medical information.

• Strong scientific background in oncology, hematology, or cellular therapies is highly desirable.

• Proven ability to manage and lead a team, with experience in building and scaling Medical Information functions.

• Excellent written and verbal communication skills with a strong attention to detail. Ability to work collaboratively with cross-functional teams in a fast-paced, evolving environment.

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